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A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Short Cervical Length

Intervention: Vaginal progesterone (Drug); Placebo (Drug); Arabin Pessary (Device)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Official(s) and/or principal investigator(s):
Joseph Biggio, MD, Study Chair, Affiliation: Maternal Fetal Medicine Units (MFMU) Network

Overall contact:
Uma Reddy, MD, MPH, Phone: 301-496-1074, Email: reddyu@mail.nih.gov

Summary

This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Clinical Details

Official title: A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Delivery prior to 35 weeks or fetal loss

Secondary outcome:

Randomization to delivery interval

Gestational age at delivery

Neonatal morbidity and mortality

Lower genital tract or urinary tract infection

Physician interventions

Detailed description: Multiple gestation increases the risk of preterm delivery. Babies born preterm have increased rates of neonatal mortality and long-term neurodevelopmental morbidities. Short cervical length is known to be an important risk factor for spontaneous preterm birth and to occur more frequently in women with a twin gestation. Although there is no evidence that progesterone reduces the risk of preterm birth in multifetal gestation, there is evidence that progesterone reduces the risk of prematurity in singleton gestations complicated with a short cervix. The Arabin pessary has also been shown to reduce the risk of preterm birth among singletons with a short cervix, and in a secondary subgroup analysis of a recent study of the use of pessary in multiple gestations, women with a cervical length < 25th percentile had a significantly reduced risk of the primary composite neonatal adverse outcome. Secondary analysis of studies of vaginal progesterone in multiple gestation with a short cervix also suggest a possible beneficial effect on preterm delivery. This protocol outlines a randomized trial of 600 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Twin gestation with cardiac activity in both fetuses. Higher order multifetal gestations reduced to twins, either spontaneously or therapeutically, are not eligible unless the reduction occurred before 12 weeks project gestational age (see below). 2. Gestational age at randomization between 16 weeks 0 days and 23 weeks 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age Determination in Section 3. 4.2 below; 3. Cervical length on transvaginal examination of less than 30 mm within 14 days prior to randomization by a study certified sonographer. Exclusion Criteria: 1. Cervical dilation (internal os) 2 cm or greater on digital examination or evidence of prolapsed membranes beyond the external cervical os either at the time of the qualifying cervical ultrasound examination or at a cervical exam immediately before randomization. There is no lower threshold of cervical length measurement threshold on ultrasound that is an exclusion criterion. 2. Monoamniotic gestation, due to increased risk of adverse pregnancy outcome 3. Twin-twin transfusion syndrome, due to increased risk of adverse pregnancy outcome 4. Evidence of severe IUGR (intrauterine growth restriction) (<5th percentile for gestational age) in either fetus 5. Fetal anomaly in either twin or imminent fetal demise. This includes lethal anomalies, or anomalies that may lead to early delivery or increased risk of neonatal death e. g., gastroschisis, spina bifida, serious karyotypic abnormalities). An ultrasound examination from 14 weeks 0 days to 23 weeks 6 days by project EDC (estimated date of conception) must be performed prior to randomization to evaluate the fetuses for anomalies. 6. Placenta previa, because of risk of bleeding and high potential for indicated preterm birth 7. Active vaginal bleeding greater than spotting at the time of randomization, because of potential exacerbation due to pessary placement 8. Symptomatic, untreated vaginal or cervical infection, also because of potential exacerbation due to pessary placement. Patients may be treated and if subsequently asymptomatic, randomized. 9. Rupture of membranes due to likelihood of pregnancy loss and preterm delivery as well as the risk of ascending infection which could be increased with pessary placement 10. More than six contractions per hour reported or documented prior to randomization. It is not necessary to place the patient on a tocodynamometer 11. Known major Mullerian anomaly of the uterus (specifically bicornuate, unicornuate, or uterine septum not resected) due to increased risk of preterm delivery which is unlikely to be affected by progesterone 12. Any fetal/maternal condition which would require invasive in-utero assessment or treatment, for example significant red cell antigen sensitization or neonatal alloimmune thrombocytopenia 13. Major maternal medical illness associated with increased risk for adverse pregnancy outcome or indicated preterm birth (treated hypertension requiring more than one agent, pre-gestational treatment for diabetes prior to pregnancy, chronic renal insufficiency failure defined by creatinine >1. 4 mg/dL, carcinoma of the breast, conditions treated with chronic oral glucocorticoid therapy. Specifically, patients with seizure disorders, HIV, and other medical conditions not specifically associated with an increased risk of indicated preterm birth are not excluded. Prior cervical cone/LOOP/LEEP is not an exclusion criterion. 14. Planned cerclage or cerclage already in place since it would preclude placement of a pessary 15. Planned indicated delivery prior to 35 weeks 16. Planned or actual progesterone treatment of any type or form after 14 weeks 6 days during the current pregnancy 17. Allergy to progesterone or excipients in the study drug or placebo 18. Participation in another interventional study that influences gestational age at delivery or neonatal morbidity or mortality 19. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, do not have to be excluded. 20. Prenatal care or delivery planned elsewhere unless the study visits can be made as scheduled and complete outcome information can be obtained

Locations and Contacts

Uma Reddy, MD, MPH, Phone: 301-496-1074, Email: reddyu@mail.nih.gov

University of Alabama - Birmingham, Birmingham, Alabama 35294, United States; Not yet recruiting
Stacy Harris, RN BSN, Phone: 205-934-1322, Email: stacylharris@uabmc.edu
Alan TN Tita, MD, Principal Investigator

Stanford University, Stanford, California 94305, United States; Not yet recruiting
Cynthia Willson, RN BSN, Phone: 650-724-6372, Email: cwillson@stanford.edu
Yasser El-Sayed, MD, Principal Investigator

University of Colorado, Denver, Colorado 80045, United States; Not yet recruiting
Kathy Hale, RN BSN, Phone: 303-724-6685, Email: kathy.a.hale@ucdenver.edu
Kent Heyborne, MD, Principal Investigator

Northwestern University-Prentice Hospital, Chicago, Illinois 60611, United States; Not yet recruiting
Gail Mallett, Phone: 312-503-3200, Email: g-mallett@northwestern.edu
William Grobman, MD, Principal Investigator

Columbia University, New York, New York 10032, United States; Not yet recruiting
Sabine Bousleiman, Phone: 212-305-4348, Email: sb1080@columbia.edu
Ronald Wapner, MD, Principal Investigator

University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599, United States; Not yet recruiting
Kelly Clark, RN, Phone: 919-350-6117, Email: kelly_clark@med.unc.edu
John M Thorp, Jr., MD, Principal Investigator

Duke University, Durham, North Carolina 27710, United States; Not yet recruiting
Tammy S Bishop, RNC MSN, Phone: 919-668-7475, Email: sincl008@mc.duke.edu
Geeta K Swamy, MD, Principal Investigator

Case Western Reserve University, Cleveland, Ohio 44109, United States; Not yet recruiting
Wendy Dalton, RNC, Phone: 216-778-7533, Email: wdalton@metrohealth.org
Edward Chien, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Not yet recruiting
Francee Johnson, RN BSN, Phone: 614-293-5632, Email: johnson.126@osu.edu
Jay D Iams, MD, Principal Investigator

Brown University, Providence, Rhode Island 02905, United States; Not yet recruiting
Donna Allard, RNC, Phone: 401-274-1122, Ext: 8522, Email: dallard@wihri.org
Dwight Rouse, MD, Principal Investigator

University of Texas - Southwestern Medical Center, Dallas, Texas 75235, United States; Not yet recruiting
Lisa Moseley, RN, Phone: 214-648-2591, Email: lisa.moseley@utsouthwestern.edu
Brian Casey, MD, Principal Investigator

University of Texas - Galveston, Galveston, Texas 77555, United States; Not yet recruiting
Ashley Salazar, RN MSN WHNP, Phone: 409-772-0312, Email: assalaza@utmb.edu
George Saade, MD, Principal Investigator

University of Texas - Houston, Houston, Texas 77030, United States; Not yet recruiting
Felecia Ortiz, RN, Phone: 713-500-6467, Email: Felecia.Ortiz@uth.tmc.edu
Suneet Chauhan, MD, Principal Investigator

University of Utah Medical Center, Salt Lake City, Utah 84132, United States; Not yet recruiting
Kim Hill, RN BSN, Phone: 801-585-5586, Email: Kim.Hill@hsc.utah.edu
Michael W Varner, MD, Principal Investigator

Additional Information

Starting date: July 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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